uses
What is BeneFix used for?BeneFix (factor IX human, recombinant) is commonly used to treat or prevent certain types of bleeding in people with hemophilia B, which is a condition that causes your blood to not clot properly. It may be used for the following.To prevent or treat bleeding episodesTo prevent or treat bleeding during or after surgeryBeneFix may also be used for other conditions as determined by your health care provider.How does BeneFix work (mechanism of action)?Hemophilia B is caused when your body does not make enough of a protein called factor IX, which normally helps your body form blood clots to stop bleeding. BeneFix works by replacing factor IX, which temporarily helps your blood to clot properly.How is BeneFix supplied (dosage forms)?Brands and other namesBeneFixDosage forms and strengths250 IU single-dose vials500 IU single-dose vials1000 IU single-dose vials2000 IU single-dose vials3000 IU single-dose vialsHow should I store BeneFix?If you or a caregiver will store BeneFix at home, store the vial in the box until you are ready to use the medicine. Store BeneFix in the refrigerator between 36 F and 46 F (2 C and 8 C) or at room temperature up to 86 F (30 C). Do not freeze. Once the medicine is prepared for use, use it within three hours or throw it away.You may keep BeneFix at room temperature up to 77 F (25 C) for up to one month. Do not keep BeneFix back in the refrigerator if it has been stored at room temperature.
how to use
liquid that is injected into a blood vessel
drug interactions
Does BeneFix interact with foods or drinks?There are no known interactions between BeneFix and foods or drinks.It is unknown if drinking alcohol will affect BeneFix. Alcohol can increase your risk of bleeding. The risk of dizziness may increase if you drink alcohol while using BeneFix. It is best to limit the amount of alcohol you drink.Does BeneFix interact with other medicines (drug interactions)?BeneFix may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
side effects
What are the most common side effects of BeneFix?The most common side effects of BeneFix are listed below. Tell your health care provider if you have any of these side effects that bother you.HeadachePain, itching, swelling, or redness near the injection siteDizzinessFeverCoughNauseaRashThere may be other side effects of BeneFix that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.What are the serious side effects of BeneFix?While less common, the most serious side effects of BeneFix are described below, along with what to do if they happen.Severe Allergic Reactions. BeneFix may cause allergic reactions, which can be serious. Stop using BeneFix and get help right away if you have any of the following symptoms of a serious allergic reaction.Breathing problems or wheezingRacing heartFever or general ill feelingSwollen lymph nodesSwelling of the face, lips, mouth, tongue, or throatTrouble swallowing or throat tightnessItching or skin rashBumps on the skin called hives that can be red, pink, white, or brown depending on your skin toneNausea or vomitingDizziness, feeling lightheaded, or faintingStomach crampsJoint painAntibodies. Your body may make antibodies (proteins made by your immune system to attack a foreign substance) against BeneFix while you are using it. These antibodies can keep BeneFix from working the way it should. Your health care provider may do blood tests to monitor your factor IX levels and look for these antibodies. Keep all of your appointments, including those for lab work, while you are using it. Tell your health care provider if you are bleeding more often or BeneFix does not seem to be working as well as it used to. Blood Clots. BeneFix may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in your lungs (pulmonary embolism) or deep veins (deep venous thrombosis or DVT). Stop using BeneFix and get emergency help if you have any of the following signs of blood clots. Chest pain or pressureFast or abnormal heartbeatTrouble breathingPain in your back, jaw, throat, or armSweating, upset stomach, vomiting, or dizzinessSudden weakness on one side of your bodySudden and severe headacheSlurred speech or trouble understanding speechPain, swelling, or tenderness in your arm or legVision lossBulging eyes Double vision
overdose and misseddose
What should I do if I accidentally use too much BeneFix?If you or someone else has used too much BeneFix, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.What should I do if I miss a dose of BeneFix?Missing doses of BeneFix can cause it to not work. So, it is important not to miss or skip doses.If a health care provider gives you BeneFix, they will make sure you are receiving it as scheduled. If you miss an appointment to get your BeneFix dose, call to make another appointment as soon as possible. If you get your BeneFix doses at home and miss a dose, call your health care provider for instructions.
warnings and Precautions
Who should not use BeneFix?Allergies to Ingredients. People who are allergic to any of the following should not use BeneFix.BeneFixFactor IX human, recombinantHamster proteinsAny of the ingredients in the specific product dispensedYour pharmacist can tell you all of the ingredients in BeneFix.What should I know about BeneFix before using it?Do not use BeneFix unless it has been prescribed to you by a health care provider. Use it as prescribed. This medicine is given into one of your veins. If you use BeneFix at home, make sure that you or a caregiver understands how to properly prepare and use it. Read the “Instructions for Use†that come with your medicine. If you have any questions, talk to your health care provider.Do not share BeneFix with other people, even if they have the same condition as you. It may harm them.Keep BeneFix out of the reach of children. As this medicine may be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.Your health care provider will likely monitor your blood tests while you are being treated with BeneFix. Keep all appointments to have your blood checked.If you are using BeneFix at home to treat a bleeding episode, call your health care provider or get medical care right away if your bleeding does not stop. What should I tell my health care provider before using BeneFix?Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if BeneFix is right for you.In particular, make sure that you discuss any of the following.Current and Past Health Conditions. Tell your health care provider if you have any of the following.History of blood clotsHave inhibitors or antibodies to factor IXLiver problemsOther Medicines and Supplements. BeneFix may interact with other medicines and supplements. Before using BeneFix, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.Pregnancy. It is not known if or how BeneFix could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.Breastfeeding. It is not known if BeneFix passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use BeneFix while breastfeeding.How can I get more information about BeneFix?For more information about BeneFix, you can visit the drugmaker’s website at www.benefix.com or call them at 800-438-1985.
about
BeneFix is medicine that is given as an injection to treat or prevent bleeding in certain people with hemophilia B. It works by replacing factor IX, which temporarily helps your blood to clot properly. Common side effects include headache and pain where you get this medicine. Get emergency help if you have trouble breathing, chest pain, vision changes, or sudden weakness on one side of your body.